Shapiro v. Secretary of Health & Human Services

101 Fed. Cl. 532, 2011 U.S. Claims LEXIS 2173, 2011 WL 5543699
CourtUnited States Court of Federal Claims
DecidedOctober 31, 2011
DocketNo. 99-552V
StatusPublished
Cited by506 cases

This text of 101 Fed. Cl. 532 (Shapiro v. Secretary of Health & Human Services) is published on Counsel Stack Legal Research, covering United States Court of Federal Claims primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Shapiro v. Secretary of Health & Human Services, 101 Fed. Cl. 532, 2011 U.S. Claims LEXIS 2173, 2011 WL 5543699 (uscfc 2011).

Opinion

OPINION

ALLEGRA, Judge:

Petitioner, Elizabeth Shapiro, seeks review of a decision issued by Special Master Christian Moran denying her petition for vaccine injury compensation. Petitioner brought this action pursuant to the National Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-10 to 300aa-34 (2006), alleging that she suffers from hypothyroidism and Systemic Lupus Erythematosus (SLE) as a result of hepatitis-B vaccinations that she received. On review, Special Master Moran denied compensation, finding that Ms. Shapiro’s illnesses were not caused by the hepatitis-B vaccinations. For the reasons that follow, this court affirms, in part, and reverses, in part, that decision.

1. BACKGROUND

A brief recitation of the facts provides necessary context.

Petitioner was born in 1950 and is a nurse-practitioner. She has three children and her husband is a pediatrician. The record contains no contemporaneous medical records suggesting that petitioner had either of the illnesses in question prior to receiving her first hepatitis-B vaccination in 1992. The record reflects that petitioner’s only medical visits before the vaccinations were routine checkups with Dr. Sylvan Frieman, her gynecologist. Dr. Frieman submitted statements for the record indicating that petitioner was healthy prior to receiving the vaccinations in question. Petitioner’s employer, Dr. Kenneth Klebanow, filed a similar statement.

On April 13, 1992, petitioner received the first of three hepatitis-B vaccinations. On April 29, 1992, she visited Dr. Frieman and reported abdominal bloating and weight gain. Dr. Frieman’s records do not reflect when these symptoms began.

On September 21,1992, petitioner received her second hepatitis-B vaccination. On October 19, 1992, she visited Dr. Richard Berg, an internist and infectious disease specialist, complaining of a five-day history of severe headache and neck ache; lightheadedness; a rapid, irregular heartbeat; and an extended menstrual period.2 That same day, testing revealed that petitioner’s thyroid stimulating hormone was ten times the normal level, a result indicative of hypothyroidism. On October 21, 1992, Dr. Berg prescribed Syn-throid to treat petitioner’s hypothyroidism. Notes from a follow-up visit with Dr. Berg that occurred approximately one month later indicate that petitioner’s palpitations and lightheadedness had abated and that her menstrual period had improved.

On February 8, 1993, petitioner received her third and final hepatitis-B vaccination. Petitioner returned to Dr. Berg twice in March of 1993, complaining of worsening symptoms, and reporting palpitations, nausea and abdominal pain. Dr. Berg adjusted petitioner’s dosage of Synthroid and referred her back to Dr. Frieman, as well as to a new doctor, Dr. Ronald L. Ginsburg, a gastroen-terologist. Petitioner visited Dr. Ginsberg in April of 1993, complaining of constipation, weight gain, prolonged menstrual periods, palpitations and lightheadedness. Shortly after this visit, Dr. Ginsberg wrote Dr. Berg, summarizing his observations. In that letter, which was dated April 22, 1993, Dr. Ginsberg stated—

[Ms. Shapiro] dates the onset of her current illness to about October of 1991 with progressively worsening constipation for the next approximately year. She also suffered a certain amount of weight gain and finally, had rather prolonged menstrual periods. In addition, she developed palpitations and a lightheadedness and a very slow pulse rate for her, between 48-60. [534]*534She began feeling chest pressure and at that point was seen [by Dr. Berg].

Although this passage of the letter suggested that petitioner’s symptoms began before her first hepatitis-B vaccination, that notion is contradicted at a later point in the same letter. On the second page of his letter, Dr. Ginsberg wrote: “[i]nterestingly, [Ms. Shapiro] notes that she had hepatitis-B vaccine which was done about a few weeks before she began having her initial problem, and then a booster which was a few weeks before her recurrent problem.” Because petitioner had her first hepatitis-B vaccination on April 13, 1992, this second statement suggests that petitioner’s “initial symptoms” began in late April of 1992.

On July 23, 1993, petitioner filed an incident report with the Vaccine Adverse Event Reporting System in which she indicated that her symptoms first occurred after her first hepatitis-B immunization. From that point on, petitioner’s medical records consistently reflect that, in providing her medical history on a half a dozen or more occasions, she told her doctors that her symptoms began after her first vaccination.3

At or about the time she filed her incident report, petitioner asserts that she began experiencing symptoms associated with SLE. On July 7, 1993, she saw Dr. Harvey Schon-wald, a urologist, due to what she believed were symptoms of hematuria — the presence of red blood cells in her urine. Dr. Sehon-wald’s records indicate that she had been experiencing this symptom for approximately two months. A cystoscopy (an endoscopy of the urinary bladder) taken at this time did not reveal the source of the hematuria. On a July 28, 1993, visit with Dr. Berg, petitioner also mentioned having joint pain. More than a year later, on August 2, 1994, petitioner had an antinuclear antibody test which was positive, another indication of SLE. Throughout this period, petitioner visited Dr. Joyce Burd, a rheumatologist, who catalogued petitioner’s many symptoms. On September 2, 1994, Dr. Burd wrote that petitioner “probably” had SLE, the first mention of this disease in any medical record. From this point forward, petitioner’s health deteriorated. Hundreds of pages of records demonstrate that she has continued to experience ill health up to and including the present time.

On August 2, 1999, petitioner filed her vaccine petition. In April of 2000, the special master originally assigned to this matter stayed the ease, apparently hoping it would be settled under a global resolution of numerous hepatitis-B cases filed at or around that time. That settlement, however, never materialized.

Subsequently, petitioner filed several sets of medical records and a number of expert reports. Among those opinions was one from Dr. Joseph Bellanti, rendered in June 2006. Dr. Bellanti opined that Ms. Shapiro’s symptoms worsened after each dose of the hepatitis-B vaccination, a causation pattern known as “ehallenge-rechallenge.” He opined that this sequence of adverse reactions resulted in the development of SLE. On January 8, 2007, Ms. Shapiro filed a report by a second expert, Dr. Yehuda Shoenfield, who serves as the head of the Center for Autoimmune Diseases at Sheba Medical Center, Tel-Aviv University, Israel.4 Dr. Shoen-field opined that Ms. Shapiro likely had a genetic predisposition to develop autoimmune diseases and that the hepatitis-B vaccine triggered her autoimmune condition. Dr. Shoenfeld linked the three hepatitis-B vaccinations received by Ms. Shapiro to her development of thyroid disease and SLE. For its part, respondent provided expert reports from two doctors, Dr. Alan Brenner and Dr. [535]*535Brian Ward. Both concluded that there was no association between Ms. Shapiro’s medical conditions and her receipt of the hepatitis-B vaccine.

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101 Fed. Cl. 532, 2011 U.S. Claims LEXIS 2173, 2011 WL 5543699, Counsel Stack Legal Research, https://law.counselstack.com/opinion/shapiro-v-secretary-of-health-human-services-uscfc-2011.